Fractional Clinical Operations Leadership for Emerging Biotech

On-demand senior level planning and execution without committing to a full-time hire.

How can I help?

Fractional Head of Clinical Operations / Clinical Program Leadership

  • High-impact leadership without the full time hire

  • Support available for both short-term planning and longer-term execution

Cross-Functional Planning and Execution

  • Integrated planning across Clinical, CMC, Regulatory, Quality, and Finance

  • Bringing stakeholders together around a clear, executable plan

  • Program-level governance structures and risk management

Trial Start-Up Accelerator Package

  • Targeted engagement to accelerate trial planning and initiation

  • Aligning study design with the optimal operational approach

CRO and Vendor Selection & Management

  • Selecting, contracting, and launching CROs and vendors

  • Ongoing oversight and governance

Resource Planning and Outsourcing Strategy

  • Portfolio or Program level resource planning

  • “Build vs. buy” decision support

Budgeting and Forecasting

  • Build bottoms-up clinical program budgets

  • Improve transparency for Sr. Leadership and investors

  • Map out cash burn against expected value inflection points

John Heyburn Bio

John is a senior Clinical Operations leader with more than 20 years of experience directing global drug development programs, primarily in oncology. His background includes building and leading Clinical Operations organizations and overseeing clinical programs from pre-IND through mid-stage and large, global Phase 3 trials. John has been involved in planning and leading over 50 clinical programs.

He has served in Vice President and Senior Vice President roles at early-stage and growth-stage biotechnology companies, where he was a member of Senior Management and R&D Leadership Teams. In these roles, John partnered closely with C-suite executives and Boards to translate development strategy into executable clinical and operational plans, with responsibility spanning portfolio and program planning, Contract Research Organization (CRO) and vendor strategy, budgeting and forecasting, governance, and operational decision-making across multiple programs.

John has built and led several high-performing, fit-for-purpose Clinical Operations teams and served as a Global Program Leader with accountability for integrated development strategy and cross-functional execution. He takes a pragmatic, hands-on approach, working closely with teams and vendors to ensure alignment and accountability, while maintaining the senior perspective required to anticipate risk, guide trade-offs, and adjust plans as conditions change. Today, John works independently with biotech leadership teams to provide on-demand, experienced clinical operations support focused on reliable execution of complex development programs.

I welcome the opportunity to discuss your needs in more detail.

Please contact me at:

  • engage@heyburnbio.com

  • Drop your information in below

  • Feel free to give me a call directly at 732-456-7275.